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Senior Specialist, Medical Writing (Manager)
AbbVieMinato City, Tokyo, Japan17日前
職務内容の詳細Prepare NDA-related documents and arrange their quality control as a lead-writer. Make every effort to prepare high-quality NDA-related documents in accordance with pharmaceutical regulations, SOPs, manuals, etc. Contribute to the decision making of the assigned JPT on behalf of Medical Writing Group. Contribute to the assigned JPT by the support of developing regulatory documents, such as answers to regulatory queries and briefing books. Formulate strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents of the project in charge and propose them to JPT. Prepare appropriate procedures for development and maintenance of NDA-related documents. Build cooperative relationships with stakeholders in Global MW. Prepare / update appropriate procedures for the vendor management. Conduct liaison activities with the vendor regarding preparation of NDA-related documents. Support to develop other medical writers who they cooperate with, with the support of the supervisors if necessary. Cooperate with the Group Manager / TA Manager for the management and operation of Medical Writing Group, from the specialist’s perspective. Give advises on the document structure and contents of NDA-related documents of the assigned JPT, based on the medical writing industry tendencies and abundant experiences. Prepare appropriate procedures for development and maintenance of NDA-related documents, within medical writing group and / or in cooperation with the related departments. Contribute to develop other medical writers and JD members who they cooperate with by offering training etc. Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or other related academic area or equivalent ability is required. Master’s or doctor’s degree is preferred. TOEIC 700 or more or equivalent English communication skill are required. At least 5 years’ experience in or equivalent skill for clinical development, regulatory affairs, post-marketing surveillance including any medical writing experience. Experience of attending the medical writing training course hosted by an organization (e.g., Union of Japanese Scientists and Engineers, Japan Medical and Scientific Communicators Association) related to medical writing is preferred.
Purpose Statement
- Prepare high-quality and accurate NDA-related documents (CSR, CTD, etc.) in accordance with regulatory requirements based on policies of global R&D and Japan Development.
- Formulate strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents as a lead-writer of the project in charge.
Major Responsibilities :
For Senior Specialist
For Senior Specialist (In addition to above )
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Senior Specialist • Minato City, Tokyo, Japan
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